BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1902009 · Received November 12, 2010

    Report

    Report Number
    3004742046-2010-00539
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 21, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE PATIENT. THERE WAS NO DEVICE MALFUNCTION REPORTED. HYPOTENSION MAY OCCUR DURING THIS TYPE OF PROCEDURE AND IS LISTED IN THE INSTRUCTIONS FOR USE AS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE PRODUCT. INFORMATION AVAILABLE IN THE CASE DESCRIPTION IS NOT SUFFICIENT TO DETERMINE A RELATIONSHIP BETWEEN THE EVENT AND THE ABBOTT VASCULAR PRODUCT. A DEFINITIVE CAUSE FOR THE REPORTED PATIENT ADVERSE EVENT AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, HOWEVER, THERE WAS NO INDICATION OF ANY PRODUCT DEFICIENCIES WHICH COULD HAVE CONTRIBUTED TO THE OUTCOME OF THE PROCEDURE. HYPOTENSION MAY OCCUR DURING CAROTID INTERVENTIONAL PROCEDURES AND IT IS ANTICIPATED RESPONSE OF THE HUMAN BODY TO STIMULUS OF THE CAROTID BULB.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT ON (B)(6) 2010, THE PATIENT EXPERIENCED HYPOTENSION DURING THE PROCEDURE AFTER BALLOON ANGIOPLASTY IN THE RIGHT INTERNAL CAROTID ARTERY WITH AN UNKNOWN BALLOON. THE PATIENT'S BASELINE BLOOD PRESSURE WAS 100 SYSTOLIC AND RETURNED TO BASELINE PRIOR TO DISCHARGE ON (B)(6) 2010. THE PATIENT WAS TREATED WITH A NEOSYNEPHRINE DRIP DURING HOSPITALIZATION AND WAS STARTED ON SUDAFED TWICE A DAY UPON DISCHARGE. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH FILED, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE HYPOTENSION BEGAN AFTER POST DILATATION OF THE ACCULINK STENT USING A 6 X 20 MM VIATRAC BALLOON. WHILE THE PATIENT WAS ON A NEOSYNEPHRINE DRIP, THE PATIENTS SYSTOLIC BLOOD PRESSURE REACHED A LOW OF 72. THE PATIENTS BASELINE BLOOD PRESSURE PRIOR TO THE PROCEDURE WHILE ON ANTI-HYPERTENSIVE MEDICATION WAS 120/69. THE ANTI-HYPERTENSIVE MEDICATIONS WERE HELD AFTER THE PROCEDURE AND WERE RESUMED BY (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT NA 9050551

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention OTHER: BIVALIRUDIN| EMBOLIC PROTECTION: RX ACCUNET ((B)(4))| 6 X 20 MM VIATRAC ((B)(4))